FDA Details Risk Reduction In Biologic Clinical Trials

Law360, New York (July 3, 2013, 7:19 PM EDT) -- The U.S. Food and Drug Administration released guidance describing how drugmakers involved in cellular and gene therapy can structure early stage clinical trials, describing the approaches needed to minimize the distinct risks of such biologic products.

The July 3 guidance applies primarily to phase 1 trials aimed at getting a basic understanding of therapies that introduce healthy cells into the body to repair damaged tissue or use various techniques to attack gene mutations. “The primary objective should be an evaluation of safety,” especially for first-in-human trials,...